Actively Recruiting
Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)
Led by Baylor Research Institute · Updated on 2025-11-10
24
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Based on a central role of inflammation in pancreas cancer, the role of IL 1 in acute and chronic inflammation , the inhibitory effect of IL 1 alfa and beta by anakinra and preliminary experience with anakinra in combination with chemotherapy in metastasis (with FOLFIRINOX) and localized disease (with gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.
CONDITIONS
Official Title
Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma, including mixed subtypes with majority ductal
- Resectable, locally advanced, or potentially resectable pancreatic adenocarcinoma
- American Joint Committee on Cancer Stage I to III pancreatic carcinoma
- Eastern Cooperative Oncology Group Performance Status of 0 to 1
- Serum albumin level greater than or equal to 2.0 g/dL
- Adequate blood cell counts: absolute neutrophil count at least 1500/mm3, platelets at least 70,000 x 10^3/µl, hemoglobin at least 9 g/dL without recent transfusion
- Adequate liver function: total bilirubin less than or equal to 2 times upper limit of normal, ALT and AST less than or equal to 2.5 times upper limit of normal
- Adequate kidney function with serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 50 mL/min
- Agreement to use contraception during the study and for one month after last Anakinra dose (for women of childbearing potential and men)
- Ability to understand and sign informed consent
- Accessible for treatment and follow-up
You will not qualify if you...
- Under 18 years of age
- History of organ transplant
- Islet cell neoplasms
- Stage IV pancreatic carcinoma
- Active, uncontrolled infections requiring systemic therapy
- Known active hepatitis B or C infection
- Clinically significant cirrhosis
- HIV positive status
- Current active immunosuppressive therapy (e.g., cyclosporine, tacrolimus)
- Major surgery or vascular device placement within 2 weeks before treatment start
- Prior chemotherapy or radiation for pancreatic cancer
- Allergy or hypersensitivity to study drugs
- Participation in other therapeutic clinical trials with investigational drugs within 5 half-lives prior to study
- Previous or current treatment with IL-1 inhibitors such as Anakinra or Canakinumab
- Other malignancies within 5 years except certain skin or cervical cancers unless recurrence risk is less than 5%
- Significant cardiac disease within last 6 months
- Severe or uncontrolled medical conditions deemed unsuitable by investigator
- Peripheral sensory neuropathy grade 2 or higher at baseline
- Abnormal liver tests: total bilirubin greater than 2 times ULN or AST/ALT greater than 5 times ULN
- Serum albumin less than 2.0 g/dL
- Abnormal blood counts: ANC less than 1500/mm3, platelets less than 70,000 x 10^3/µl, hemoglobin less than 9 g/dL without transfusion
- Pregnant or nursing women
- No signed informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor University Medical Center, Charles A Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
P
Page Blas, MA
CONTACT
J
Joyce Ghormley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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